JD Supra1d
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications
FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...
FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
A plan for the US Food and Drug Administration to propose banning formaldehyde and certain formaldehyde-releasing chemicals ...
New guidelines for lead in baby food set low standards, but not enforceable
After repeated calls for action, the FDA has set a guideline for lead in baby food -- but it is not the end of the fight for ...
JD Supra13d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
The American Journal of Managed Care11d
FDA Quietly Removes Draft Guidance on Diversity in Clinical Trials Following Executive Order on DEI
The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...
GlobalData on MSN13d
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
News Medical on MSN15h
New guidelines urge caution with ketamine use for mental health treatment
The anesthetic ketamine is being hailed as a breakthrough therapy for people with post-traumatic stress disorder (PTSD), treatment-resistant depression and other mood disorders.
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...